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Brachial Plexus Birth PalsyNCT07654504

Validity and Reliability of the Turkish Version of the Impact of Brachial Plexus Injury Questionnaire (IMBPIQ)

An observational study of Brachial Plexus Birth Palsy and Brachial Plexus Palsy, run by Biruni University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of this methodological study is to translate the Impact of Brachial Plexus Injury Questionnaire (IMBPIQ) into Turkish, culturally adapt it, and evaluate its validity and reliability for use in adults with brachial plexus birth palsy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Questionnaire Assessment Battery
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Aug 2026to 1 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will consist of adults aged 18 years and older with a diagnosis of brachial plexus birth palsy who are able to read, write, speak, and understand Turkish. Participants will be recruited on a voluntary basis from individuals with brachial plexus birth palsy who meet the eligibility criteria. Both female and male participants will be included.

Who may be able to join

  • Being 18 years of age or older.
  • Having a diagnosis of brachial plexus birth palsy.
  • Having the ability to read, write, speak, and understand Turkish.
  • Agreeing to participate voluntarily in the study and signing the informed consent form.

Who cannot join

  • Having a neurological disease.
  • Having another orthopedic problem or a history of trauma in the affected upper extremity.
  • Having a severe cognitive or communication impairment that may prevent completion of the questionnaires or understanding of the study instructions.
  • Having a history of systemic disease requiring an acute attack or hospitalization within the last three months.
  • Being pregnant or being in the postpartum period of less than 6 months.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fahri Dogukan Bozkurt, Physiotherapist, MSc Student contact

+905392870087

fahrib@biruni.edu.tr

Zeynep Hosbay, Physiotherapist, Prof. contact

+905055034279

zhosbay@biruni.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Biruni University

    Istanbul, Istanbul, 34015

    Fahri Dogukan Bozkurt, Physiotherapist, MSc Student, +905392870087, fahrib@biruni.edu.tr

    Zeynep Hosbay, Physiotherapist, Prof., +905055034279, zhosbay@biruni.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

The aim of this methodological study is to translate the Impact of Brachial Plexus Injury Questionnaire (IMBPIQ) into Turkish, culturally adapt it, and evaluate its validity and reliability for use in adults with brachial plexus birth palsy. The study will include 50 adult participants aged 18 years and older with a diagnosis of brachial plexus birth palsy. Participants will complete the Turkish version of the IMBPIQ, as well as the Disabilities of the Arm, Shoulder and Hand questionnaire and the Short Form-36. The psychometric properties of the Turkish IMBPIQ will be examined using reliability and validity analyses, including internal consistency, test-retest reliability, and construct validity.

Read the detailed description

The Impact of Brachial Plexus Injury Questionnaire (IMBPIQ) is a disease-specific patient-reported outcome measure developed to evaluate the impact of brachial plexus injury on daily life, functional status, and psychosocial well-being. There is currently no Turkish version of the IMBPIQ with established validity and reliability. Considering the increasing importance of culturally adapted patient-reported outcome measures, this study aims to translate the IMBPIQ into Turkish, perform its cultural adaptation, and evaluate the validity and reliability of the Turkish version for use in adults with brachial plexus birth palsy.

This study is designed as a methodological validity and reliability study. Written permission has been obtained from the original developers of the IMBPIQ for translation, cultural adaptation, and psychometric testing. The English version of the questionnaire will be translated into Turkish by independent translators. The translated versions will be reviewed by a committee, and a single Turkish version will be created based on consensus. This Turkish version will then be back-translated into English by a translator whose native language is English and who is proficient in both languages. The original version and the back-translated version will be compared in terms of semantic equivalence, linguistic appropriateness, and cultural adaptation, and the final Turkish version of the questionnaire will be established.

A pilot test will be conducted with 10 participants to evaluate the comprehensibility and applicability of the Turkish version of the questionnaire. Based on the feedback obtained from the pilot test, final revisions will be made before the main study. The main study will include 50 adult participants aged 18 years and older with a diagnosis of brachial plexus birth palsy. Participants will complete a sociodemographic and clinical information form, the Turkish version of the IMBPIQ, the Disabilities of the Arm, Shoulder and Hand questionnaire, and the Short Form-36.

The IMBPIQ consists of 43 items and includes four main subdomains: symptoms, limitations, emotional status, and expected or achieved improvement after surgery or treatment. Raw scores obtained from the responses are converted into normalized standard scores ranging from 0 to 100. The disability domain score is calculated using the symptoms, limitations, and emotional status subdomains, with higher scores indicating greater disability and psychosocial impact. The improvement domain score reflects the expected or achieved improvement related to surgery or treatment, with higher scores indicating greater expected or perceived improvement.

The Disabilities of the Arm, Shoulder and Hand questionnaire will be used to evaluate upper extremity symptoms and functional disability. The Short Form-36 will be used to assess health-related quality of life. These measures will be used to examine the construct validity of the Turkish IMBPIQ through correlations with related patient-reported outcome measures.

Statistical analyses will be performed using IBM SPSS Statistics software. Descriptive statistics will be calculated to summarize participants' sociodemographic and clinical characteristics. Internal consistency reliability will be evaluated using Cronbach's alpha coefficient. Test-retest reliability will be examined by re-administering the Turkish IMBPIQ to 30 participants after a two-week interval, and agreement between the two assessments will be analyzed using the intraclass correlation coefficient. Construct validity will be assessed using Pearson or Spearman correlation analyses between the IMBPIQ scores and the scores obtained from the Disabilities of the Arm, Shoulder and Hand questionnaire and the Short Form-36. The statistical significance level will be accepted as p < 0.05.

Being tested
Questionnaire Assessment Battery
Keywords
Impact of Brachial Plexus Injury Questionnaire, IMBPIQ, Brachial Plexus Birth Palsy, Obstetric Brachial Plexus Palsy, Turkish Version, Validity, Reliability, Cultural Adaptation, Patient-Reported Outcome Measure, DASH, Short Form-36, Test-Retest Reliability, Internal Consistency, Construct Validity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Questionnaire Assessment BatteryOther

    Participants will complete the Turkish version of the Impact of Brachial Plexus Injury Questionnaire, the Disabilities of the Arm, Shoulder and Hand questionnaire, and the Short Form-36.

Study groups in NCT07654504
Study groupRoleWhat they receive
Adults With Brachial Plexus Birth PalsyAdults aged 18 years and older with a diagnosis of brachial plexus birth palsy who will complete the Turkish version of the Impact of Brachial Plexus Injury Questionnaire and related assessment tools.
Receives: Other: Questionnaire Assessment Battery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validity and Reliability of the Turkish IMBPIQ

    The validity and reliability of the Turkish version of the Impact of Brachial Plexus Injury Questionnaire will be evaluated. Reliability will be assessed using internal consistency and test-retest reliability analyses. Validity will be assessed using construct validity analyses through correlations with related patient-reported outcome measures.

    Measured: Baseline and after 1 week

Secondary outcomes (2)
  1. Upper Extremity Disability

    Upper extremity disability will be assessed using the Disabilities of the Arm, Shoulder and Hand questionnaire. Higher scores indicate greater upper extremity disability.

    Measured: Baseline

  2. Health-Related Quality of Life

    Health-related quality of life will be assessed using the Short Form-36. The scale includes subdomains related to physical and mental health, with higher scores indicating better health status.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07654504
Sponsor's protocol ID
2024-BİAEK/19-38
Status last verified
Jun 2026
First submitted
13 Jun 2026
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared in order to protect participant privacy, confidentiality, and ethical data protection principles.

Questions about this trial

What is this clinical trial studying?

An observational study of Brachial Plexus Birth Palsy and Brachial Plexus Palsy, run by Biruni University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fahri Dogukan Bozkurt, Physiotherapist, MSc Student (+905392870087, fahrib@biruni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validity and Reliability of the Turkish IMBPIQ (time frame: Baseline and after 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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